(115 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
Nitrile Blue Powder-Free Examination Gloves
This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Blue Powder-free Examination Gloves." It is a clearance letter, not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies of a device related to AI, image analysis, or similar technologies.
The document only provides information about the chemical permeation resistance of the gloves to various chemotherapy drugs.
Thus, I cannot fulfill your request for the following reasons:
- No AI/ML Device: The device described (nitrile examination gloves) is a physical medical device, not a software or AI/ML-based device.
- No Performance Study Data of the Type Requested: The document details the results of ASTM D6978, which is a chemical permeation test, not a performance study involving test sets, expert readers, ground truth, or MRMC analysis for an AI algorithm.
- No Acceptance Criteria for AI/ML Performance: The "acceptance criteria" presented are minimum breakthrough times for chemotherapy drugs, not metrics like sensitivity, specificity, AUC, or other measures common for AI/ML diagnostic tools.
Therefore, I cannot extract the information asked for in points 1-9 of your prompt from the provided text.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.